After welcoming a new CEO and entertaining a potential buyout last year, West Coast cancer specialist Seagen is again adding to its trophy case of regulatory wins.
The FDA on Thursday granted an accelerated approval to Seagen's Tukysa as a second-line treatment along with Herceptin for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer. Specifically, the drug is approved in combination with Roche's Herceptin for patients whose cancer progressed after treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
With the approval, the combination becomes the first FDA-approved treatment for HER2-positive metastatic colorectal cancer, Seagen noted.
In granting the nod, the FDA leveraged data from the phase 2 MOUNTAINEER trial. In the study, the Tukysa and Herceptin combo was studied in 84 patients who had received previous standard-of-care therapies. Three patients in the study experienced complete responses, or a clearing of cancer, while 29 patients experienced partial responses, according to Seagen. In total, a 38% overall response rate was recorded.
Since this is an accelerated approval, the Tukysa and Herceptin combo might need to prove its worth in a confirmatory trial to keep the nod in place, Seagen noted. The company has an ongoing phase 3 study intended to fulfill that post-approval requirement.
This is Tukysa's second FDA green light after its 2020 approval in combination with Herceptin and the chemotherapy capecitabine to treat adults with advanced unresectable or metastatic HER2-positive breast cancer.
For Seagen, it follows an eventful and tumultuous 2022. Founder and former CEO Clay Siegall was arrested last April on allegations of domestic violence and resigned the following month. In November, the company brought in Novartis' former pharma head David Epstein to serve as its new CEO.
In late December, The Seattle Times reported that Siegall wouldn't face charges related to his arrest.
Besides the CEO transition, Seagen also reportedly eyed a buyout in 2022. Last July, The Wall Street Journal reported that Merck and Seagen were nearing a $40 billion deal, but that transaction didn’t come together. In August, Bloomberg reported that the companies couldn't agree on a price.
Now, as things appear to be steadying at Seagen, the company is focused on executing with its own portfolio and pipeline. Besides Tukysa, the company markets targeted cancer drugs Adcetris, Padcev and Tivdak. The company will have 18 clinical programs in progress by the end of 2023, executives said last week at the J.P. Morgan Healthcare Conference.